Dissolution and bracketing [Regulatives / Guidelines]

posted by Susanh – Iceland, 2020-04-03 11:56 (334 d 15:04 ago) – Posting: # 21314
Views: 1,203

Hi and thanks for your response.
Just to make sure I’m understanding correctly:
Do I need to do a BE study on all the strengths that are not showing similarity in dissolution
Or
Can I use bracketing approach and just add one study, either on the lowest strength or the strength differing most in dissolution?
Thanks for your help.
Susan

Complete thread:

Activity
 Admin contact
21,361 posts in 4,461 threads, 1,493 registered users;
online 14 (0 registered, 14 guests [including 4 identified bots]).
Forum time: Thursday 02:01 CET (Europe/Vienna)

Being really good at C++ is like being really good
at using rocks to sharpen sticks.    Thant Tessman

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5